‘Informal’ Process May Speed Harmonized Quality Standards, U.S., UK Pharmacopeias Say

The U.S. Pharmacopeial Convention (USP) and the British Pharmacopoeia (BP) have developed two drug-product quality standards under a new, flexible approach that signals a drive toward speedier harmonization — and a potential break for drugmakers.

The standards developed under the new “informal” harmonization effort took only one year to reach draft status and resulted in the first drug products to be unified in advance of inclusion in their respective compendia, the pharmacopeias said May 15.

The draft standards relate to analytical procedures for eye drop medications dorzolamide hydrochloride ophthalmic solution and dorzolamide hydrochloride-timolol maleate ophthalmic solution.

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